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Chronic Hepatitis C and Insulin Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707603
Recruitment Status : Completed
First Posted : July 1, 2008
Last Update Posted : July 14, 2015
Information provided by (Responsible Party):
Dr Jerry Greenfield, Garvan Institute of Medical Research

Brief Summary:
Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with >200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity and heart disease are extremely common. This study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to CHC

Condition or disease
Hepatitis C Insulin Resistance

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection
Study Start Date : May 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Hepatitis C subjects
Due to start therapy for Hepatitis C
Healthy males

Primary Outcome Measures :
  1. Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. insulin resistance post treatment of Hep C [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hepatitis C patients

Inclusion Criteria:

  • Caucasian male
  • Age: 25-55 years
  • Chronic Hepatitis C (PCR positive) and fibrosis ≤ F2 (if liver biopsy done)
  • Genotypes 1 or 3
  • Due to commence antiviral therapy
  • BMI < 30

Exclusion Criteria:

  • Cirrhosis or F3 fibrosis on liver biopsy (if done)
  • > 20 g ETOH per day
  • Type 2 Diabetes (need an OGTT if fasting BGL> 5.7)
  • Concurrent HIV
  • Other cause of liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00707603

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Australia, New South Wales
Garvan Institute Of Medical Research
Sydney, New South Wales, Australia, 2010
Storr Liver Unit
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
Garvan Institute of Medical Research
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Principal Investigator: Donald Chisholm, MBBS, FRACP Garvan Institute of Medical Research
Principal Investigator: Jacob George, MBBS, FRACP Storr Liver Unit
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Jerry Greenfield, Head of Endocrinology Department St Vincent's Hospital Sydney, Garvan Institute of Medical Research Identifier: NCT00707603    
Other Study ID Numbers: H04/126
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Keywords provided by Dr Jerry Greenfield, Garvan Institute of Medical Research:
Insulin resistance
Liver fat
Muscle fat
Abdominal fat
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Insulin Resistance
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Glucose Metabolism Disorders
Metabolic Diseases